Device Problem
No Audible Alarm (1019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Internal cross reference: complaint pr# (b)(4).
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Event Description
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This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that they cannot hear sound from the scan room.If the operator is unable to hear the patient due to a failed microphone, there is potential for injury to the patient.This issue has been determined to be a reportable event.This issue is currently under investigation.
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Manufacturer Narrative
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The customer reported that they could not hear sound from the patient in the scan room.This issue occurred on a brilliance 64 ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site to evaluate the system.The fse confirmed the customer allegation that sound could not be heard coming from the scanner microphones.The fse checked the hardware of the microphone in the gantry and determined that the gantry microphone had failed.The gantry microphone assembly was then replaced to correct the issue.The system is operational and in clinical use.This event has been determined not to be a reportable event.
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Manufacturer Narrative
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The customer reported that they could not hear sound from the patient in the scan room.This issue occurred on a brilliance 64 ct system.The customer confirmed with the philips help desk that there was no patient impact and no harm as a result of this event.The philips field service engineer (fse) arrived at the customer site to evaluate the system.The fse confirmed the customer allegation that sound could not be heard coming from the scanner microphones.The fse checked the hardware of the microphone in the gantry and determined that the gantry microphone had failed.The gantry microphone assembly was then replaced to correct the issue.The system is operational and in clinical use.This event has been determined not to be a reportable event.
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Search Alerts/Recalls
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